Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

NCT04532099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2022-05-03

Study results available
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Summary

The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

Conditions

  • Refractive Errors
  • Ametropia

Interventions

DEVICE

Lehfilcon A contact lenses

Investigational soft contact lenses for daily wear worn in Part A of the study

DEVICE

Senofilcon A contact lenses

Commercially available soft contact lenses for daily wear worn in Part A of the study

DEVICE

Comfilcon A contact lenses

Commercially available soft contact lenses for daily wear worn in Part B of the study

DEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Trial Lead, CDMA Vision Care · Alcon Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2021-05-04
Completion
2021-05-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532099 on ClinicalTrials.gov